Court Hears Vermont Drug Safety Case

The Bush administration and a pharmaceutical company on Monday urged the U.S. Supreme Court to throw out a multimillion dollar verdict for a Vermont musician who lost her arm because of a botched injection to relieve nausea. Senator Bernie Sanders joined Senator Patrick Leahy, Representative Peter Welch and other members of Congress in urging justices to side with the Marshfield, Vt., woman and uphold the decision by the Vermont Supreme Court. In a friend-of-the-court brief, they said consumers

The Bush administration and a pharmaceutical company on Monday urged the U.S. Supreme Court to throw out a multimillion dollar verdict for a Vermont musician who lost her arm because of a botched injection to relieve nausea. Senator Bernie Sanders joined Senator Patrick Leahy, Representative Peter Welch and other members of Congress in urging justices to side with the Marshfield, Vt., woman and uphold the decision by the Vermont Supreme Court. In a friend-of-the-court brief, they said consumers cannot rely on the Food and Drug Administration alone to safeguard drug safety because the federal agency "has suffered from politicization and a bias favoring approval of new pharmaceuticals rather than ensuring the safety of the 11,000 drugs already on the market."

The congressmen told the high court that after FDA initially lets drugs onto the market, the agency then relies on an "antiquated, underfunded, and often overwhelmed" voluntary physician reporting system for discovering dangerous and sometimes life-threatening side effects. Lawsuits brought by injured consumers under state law can help ensure that manufacturers have the incentive to provide the most up-to-date warning information, they argued. In the Vermont case, a Vermont jury awarded her $6.7 million to Diana Levine after agreeing that the pharmaceutical company Wyeth should have included a stronger warning about the risks of using a method of intravenous injection to administer anti-nausea drug Phenergan.

In taking the case up to the Supreme Court, lawyers for Wyeth and the Bush administration contended that the lawsuit should have been thrown out of state court because the medication had been approved by the federal Food and Drug Administration. Federal regulatory approval, they argued, trumps any right consumers have to bring cases in state courts.

On the contrary, when Congress enacted the Food, Drug and Cosmetic Act of 1938, lawmakers never intended to slam the state courthouse doors on consumers, according to the amicus brief by Leahy, Sanders and other lawmakers.

Justices are expected to rule on the case sometime next year.